Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579111 | 12557911 | 1 | I | 20160114 | 20160714 | 20160714 | PER | US-JAZZ-2016-US-000816 | JAZZ | 0.00 | F | Y | 0.00000 | 20160714 | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125579111 | 12557911 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | 21196 | 2.25 | G | ORAL SOLUTION | |||||||
| 125579111 | 12557911 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | 21196 | ORAL SOLUTION | |||||||||
| 125579111 | 12557911 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 5 G, BID | 21196 | 5 | G | ORAL SOLUTION | |||||||
| 125579111 | 12557911 | 4 | SS | SUBOXONE | BUPRENORPHINE HYDROCHLORIDENALOXONE HYDROCHLORIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 125579111 | 12557911 | 5 | C | PRILOSEC | OMEPRAZOLE MAGNESIUM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 6 | C | Marijuana | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | UNK | U | 0 | ||||||||||
| 125579111 | 12557911 | 7 | C | NUVIGIL | ARMODAFINIL | 1 | 50 MG, UNK | U | 0 | 50 | MG | TABLET | |||||||
| 125579111 | 12557911 | 8 | C | NUVIGIL | ARMODAFINIL | 1 | 150 MG, UNK | U | 0 | 150 | MG | TABLET | |||||||
| 125579111 | 12557911 | 9 | C | Probiotic | PROBIOTICS NOS | 1 | UNK | U | 0 | ||||||||||
| 125579111 | 12557911 | 10 | C | VITAMIN D | CHOLECALCIFEROL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 11 | C | LOTEMAX | LOTEPREDNOL ETABONATE | 1 | UNK | U | 0 | EYE DROPS | |||||||||
| 125579111 | 12557911 | 12 | C | PROVIGIL | MODAFINIL | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 13 | C | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579111 | 12557911 | 14 | C | Atorvastatin | ATORVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 15 | C | LAMICTAL | LAMOTRIGINE | 1 | 200 MG, UNK | U | 0 | 200 | MG | TABLET | |||||||
| 125579111 | 12557911 | 16 | C | LAMICTAL | LAMOTRIGINE | 1 | 100 MG, UNK | U | 0 | 100 | MG | TABLET | |||||||
| 125579111 | 12557911 | 17 | C | PROZAC | FLUOXETINE HYDROCHLORIDE | 1 | UNK | U | 0 | CAPSULE | |||||||||
| 125579111 | 12557911 | 18 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 19 | C | KLONOPIN | CLONAZEPAM | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 20 | C | ZOCOR | SIMVASTATIN | 1 | UNK | U | 0 | TABLET | |||||||||
| 125579111 | 12557911 | 21 | C | ADDERALL | AMPHETAMINE ASPARTATEAMPHETAMINE SULFATEDEXTROAMPHETAMINE SACCHARATEDEXTROAMPHETAMINE SULFATE | 1 | UNK | U | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125579111 | 12557911 | 1 | Narcolepsy |
| 125579111 | 12557911 | 2 | Cataplexy |
| 125579111 | 12557911 | 4 | Pain |
| 125579111 | 12557911 | 5 | Product used for unknown indication |
| 125579111 | 12557911 | 6 | Product used for unknown indication |
| 125579111 | 12557911 | 7 | Product used for unknown indication |
| 125579111 | 12557911 | 9 | Product used for unknown indication |
| 125579111 | 12557911 | 10 | Product used for unknown indication |
| 125579111 | 12557911 | 11 | Product used for unknown indication |
| 125579111 | 12557911 | 12 | Product used for unknown indication |
| 125579111 | 12557911 | 13 | Product used for unknown indication |
| 125579111 | 12557911 | 14 | Product used for unknown indication |
| 125579111 | 12557911 | 15 | Product used for unknown indication |
| 125579111 | 12557911 | 17 | Product used for unknown indication |
| 125579111 | 12557911 | 18 | Product used for unknown indication |
| 125579111 | 12557911 | 19 | Product used for unknown indication |
| 125579111 | 12557911 | 20 | Product used for unknown indication |
| 125579111 | 12557911 | 21 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125579111 | 12557911 | Enuresis | |
| 125579111 | 12557911 | Hypokalaemia | |
| 125579111 | 12557911 | Insomnia | |
| 125579111 | 12557911 | Intentional product use issue | |
| 125579111 | 12557911 | Malaise | |
| 125579111 | 12557911 | Nausea | |
| 125579111 | 12557911 | Pain |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125579111 | 12557911 | 1 | 201302 | 2013 | 0 | |
| 125579111 | 12557911 | 3 | 201410 | 0 | ||
| 125579111 | 12557911 | 4 | 20120701 | 0 | ||
| 125579111 | 12557911 | 6 | 20151218 | 20151218 | 0 | |
| 125579111 | 12557911 | 7 | 20120801 | 20151218 | 0 | |
| 125579111 | 12557911 | 8 | 20151218 | 0 | ||
| 125579111 | 12557911 | 9 | 20151218 | 0 | ||
| 125579111 | 12557911 | 10 | 20151218 | 0 | ||
| 125579111 | 12557911 | 11 | 20151028 | 0 | ||
| 125579111 | 12557911 | 12 | 20151028 | 20151028 | 0 | |
| 125579111 | 12557911 | 13 | 20151028 | 0 | ||
| 125579111 | 12557911 | 14 | 20150909 | 0 | ||
| 125579111 | 12557911 | 15 | 20120301 | 20140915 | 0 | |
| 125579111 | 12557911 | 16 | 20150908 | 0 | ||
| 125579111 | 12557911 | 17 | 20150908 | 0 | ||
| 125579111 | 12557911 | 18 | 20150908 | 20160114 | 0 | |
| 125579111 | 12557911 | 19 | 20150126 | 0 | ||
| 125579111 | 12557911 | 21 | 20030101 | 20150904 | 0 |